Friday Feedback: Grading FDA on Opioid Prescriber Education

Experts size up FDA policies on opioids

As the opioid epidemic continues to run rampant in the U.S., there's a clear need for better prevention strategies -- including improved education and training for prescribers.

Earlier this week, FDA Commissioner Scott Gottlieb said the agency would add immediate-release opioids to the list of products for which prescribers should receive special training under the Risk Evaluation and Mitigation Strategy (REMS). However, he noted that training would remain voluntary, raising questions as to just how effective it will be in curbing overdoses and deaths among users.

MedPage Today spoke with several experts about the FDA's current policies and actions toward opioids, as well as whether prescriber training should be a mandatory component of physician education.

How appropriate is this prescriber training and how well has it worked so far?

Steven P. Stanos, MD, American Academy of Pain Medicine: It has been effective in educating providers around comprehensive assessment and management of patients requiring opioid therapy. Although the number of attendees at ER/LA REMS programming was below predetermined goals, a small number of published reports showed some sustained educational benefit, making assessing impact a challenge. AAPM feels strongly that an under-appreciated but critically important challenge remains including the lack of pain management education in medical schools, residencies, and specialty training programs. We applaud the FDA's decision to expand education to include short-acting opioid formulations and additional broader training related to pain management and assessment.

David Crabtree, MD,UC San Diego Medical Center: The training available to prescribers is appropriate, but it must not be concluded that it has worked. Furthermore, saying the training is appropriate doesn't mean that it shouldn't be revisited and improved. The various issues centered around opioids (overprescribing, overdose, addiction, etc.) could also be targeted by having training and education on pain management.

Bertha K. Madras, PhD, Harvard Medical School: Training is appropriate because medical schools and residency programs in the past 20 years did not (and in some medical schools still do not) cover pain management and addiction appropriately or of relevance to current knowledge and state of the opioid crisis.

Should it be made mandatory? Why or why not?

Stefan G. Kertesz, MD, University of Alabama at Birmingham School of Medicine: I passionately support advancing education on responsible prescribing for long- and short-acting opioids, using the CDC Guideline as a core tool. I strongly caution against our increasingly myopic focus on controlling prescriptions as the primary tool to address the utter devastation that addiction is causing right now.

Boscarino: I believe this training needs to be mandatory, given the scope of this problem.

Crabtree: Prescribers should be mandated to receive opioid REMS education. All healthcare professionals involved in opioid prescribing must be aware of the risks; if only those who want to participate compete training, we will miss the mark. Given the recent attention put on the "opioid epidemic" over the past few years, now is an opportune time to also partner with other federal and state agencies to collaborate on training/education methods (CDC opioid guidelines), as well as to develop and implement appropriate paths to satisfy required training (tie training to DEA licensing).

Stanos: Making opioid education mandatory would ensure a minimum level of knowledge among prescribers; however, this may be difficult to implement as the FDA has authority to regulate manufacturers but not physicians, and DEA has authority to register but not regulate. Greater education at the training level may have a more lasting impact on practitioner behaviors and their clinical practice, thus ensuring better care for their patients and reducing harm to the patient, their families, and the communities they live in.

Madras: The question of mandatory training does not have ready answers. Knowledge does not necessarily translate to practice. Repeated reinforcement of the training, feedback on whether an individual clinician is practicing within the current norms, case studies of likely patient encounters, educational detailing, incentives and disincentives, may be as, or more effective or combined with mandatory courses, for changing pain management practices. However, training in opioid prescribing alone will not fill the knowledge gap -- SBIRT, knowledge of medications assistance for opioid use disorder, and availability of seamless SUD treatment services, need to be addressed in updating practices.

How would you rate the agency's policies and actions on opioids overall?

Madras: The FDA increasingly is inserting itself into the opioid crisis -- it is a welcome development. I have not read the current authorization bill that outlines the boundaries of the FDA mandate, but I anticipate an expansion of its influence and regulatory oversight.

Stanos: The opioid epidemic is a complex issue in which it is challenging to assess the impact of the agency's policies. In fact, some of the problems lie outside the agency's purview. The CDC Guideline for Prescribing Opioids for Chronic Pain has helped to clarify that opioids are not a first-line treatment for pain, increased awareness of the need for careful assessment and management of patients requiring opioid analgesics, and provided guidance on risk mitigation, optimal dosing, and discontinuation. AAPM feels that any policies or guidelines should not lead to limiting access to care for those patients who could benefit from opioid analgesics when used in a responsible manner and as part of a patient-centered treatment program.

Boscarino: Our study team is currently working with the FDA on a national "Opioid Post-Marketing Observational Study." Given the scope of this problem, some of us wish the FDA would move faster with this study, but these are complex issues and the FDA and other agencies involved are trying to get this right.

Crabtree: In the context of the past 10 to 15 years, the overall FDA policies and actions on opioids have been slowly evolving. Some might say too slow. Clearly, however, some recent actions show the FDA is trying to appropriately address risk to patients and public health. The recent decision to include immediate-release opioid products on the list for REMS is a small, but significant step in the right direction. Having Opana ER off the market is another recent positive example, yet the epidemic of overdose and addiction is fueled by much more than one medication.

Kertesz: We are failing to expand addiction treatment access to the degree that it is needed. We are also failing to build policy to address the circumstances that drive drug-seeking, including the abysmal lack of social opportunity for young adults in many communities. Finally, many agencies are tacitly or actively allowing pill control efforts to devastate the lives of pain patients who were stable until their care was completely upended.

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